BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARI10A ENHANCED BED

    MDR report key: 3190729 · Received June 26, 2013

    Report

    Report Number
    0001831750-2013-05824
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 4, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP SUBMITTED TO REPORT THAT (B)(4), THE MANUFACTURER, IS RESPONSIBLE FOR ALL REGULATORY REPORTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BED CONTROLS WERE NOT WORKING. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BED CONTROLS WERE NOT WORKING. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289928 BARI10A ENHANCED BED BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1